510(k) · Cleared
ClearedBrainlab Elements Guide XT, Guide 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · QQC Brain Stimulation Programming Planning Software.
Cleared on Apr 19, 2022 as substantially equivalent to DEN210003 (Medtronic Neuromodulation, 2021) after a 124-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Apr 19, 2022
- Review
- 124 days
- Class
- Class II
- Product code
- QQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN210003 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN210003 SureTune4 SoftwareMedtronic Neuromodulation · 2021
- This deviceK213930 Brainlab Elements Guide XT, Guide 3.0Brainlab AG · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN210003 | SureTune4 Software | Medtronic Neuromodulation | 2021 | — |
| 0 (this device) | K213930 | Brainlab Elements Guide XT, Guide 3.0 | Brainlab AG | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QQC device
- #1 K243520 Bullsai Confirmscore 9.1 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN210003 | SureTune4 SoftwareSummary page 4…882.5855 Regulatory Class II Panel Neurology Predicate Devices Predicate device: SureTune4 Software (DEN210003) Contact Information Primary Contact… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN210003.
How does its category compare?
All QQC devicesQQC Brain Stimulation Programming Planning Software.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QQC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QQC
Too few QQC 510(k)s in any year since 2007 to give a median.
Recalls per year · QQC
No recall names QQC since 2007.
Adverse event reports per year · QQC
No MAUDE report names QQC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Brainlab Elements Guide XT provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Boston Scientific deep brain stimulation (DBS) devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213930 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213930: Brainlab Elements Guide XT, Guide 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213930
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026